Mixed effects of warnings on antidepressants in children Many of the studies evaluated the impact of FDA warnings about a possible increase in suicide risk among children and adolescents taking antidepressant drugs. Most studies showed decreased prescribing of antidepressants to children, along with smaller increases in antidepressant prescribing for adults.The studies reported shifts in market share to different antidepressants, with mixed evidence on the use of psychotherapy as an alternative to antidepressants. There was little information on how the warnings affected health outcomes for children and teens with symptoms of depression. However, one study suggested an increase in suicides among youths related to declines in antidepressant prescribing."Risk communication is a complex science and understanding the intended and unintended outcomes from prior FDA advisories, and label warnings may help to guide future risk communication," write Dusetzina, Higashi, and colleagues. They note that the published studies of the effects of FDA safety warnings had significant limitations. There was little or no data on how drug warnings affect patient-doctor communication, decision-making, or perceived risks.However, the studies are not the first to show unintended consequences of regulatory warnings regarding prescription drugs. "[This] potential demonstrates the challenge that policy-makers face to design risk messages that are maximally effective, specific, and that don’t become risks themselves," the researchers conclude. They call for further studies to look at how FDA advisories affect prescribing and medical practice, and to "enhance the science of risk communication regarding prescription drugs."In an accompanying editorial, Dr Gerald J. Dal Pan of the FDA's Center for Drug Evaluation and Research discusses the complex challenges involved in communicating the risks of medicines and evaluating the impact of those communications. He notes the introduction of a new type of "Drug Safety Communication" as the FDA's "primary safety communication tool for postmarket issues," with the potential to provide prescribers with a more detailed understanding of emerging issues.This article was first published at www.newswise.com
DGA warnings don't always have desired effects
Regulatory advisories show 'varied and unpredictable impact,' reports 'Medical Care.'
Mixed effects of warnings on antidepressants in children Many of the studies evaluated the impact of FDA warnings about a possible increase in suicide risk among children and adolescents taking antidepressant drugs. Most studies showed decreased prescribing of antidepressants to children, along with smaller increases in antidepressant prescribing for adults.The studies reported shifts in market share to different antidepressants, with mixed evidence on the use of psychotherapy as an alternative to antidepressants. There was little information on how the warnings affected health outcomes for children and teens with symptoms of depression. However, one study suggested an increase in suicides among youths related to declines in antidepressant prescribing."Risk communication is a complex science and understanding the intended and unintended outcomes from prior FDA advisories, and label warnings may help to guide future risk communication," write Dusetzina, Higashi, and colleagues. They note that the published studies of the effects of FDA safety warnings had significant limitations. There was little or no data on how drug warnings affect patient-doctor communication, decision-making, or perceived risks.However, the studies are not the first to show unintended consequences of regulatory warnings regarding prescription drugs. "[This] potential demonstrates the challenge that policy-makers face to design risk messages that are maximally effective, specific, and that don’t become risks themselves," the researchers conclude. They call for further studies to look at how FDA advisories affect prescribing and medical practice, and to "enhance the science of risk communication regarding prescription drugs."In an accompanying editorial, Dr Gerald J. Dal Pan of the FDA's Center for Drug Evaluation and Research discusses the complex challenges involved in communicating the risks of medicines and evaluating the impact of those communications. He notes the introduction of a new type of "Drug Safety Communication" as the FDA's "primary safety communication tool for postmarket issues," with the potential to provide prescribers with a more detailed understanding of emerging issues.This article was first published at www.newswise.com